Prescription drug · ANDA
(Sotradecol) Sodium Tetradecyl Sulfate NDC 51662-1563
Tetradecyl hydrogen sulfate (Ester) 30 mg/mL · Injection, Solution · Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1563-1 | 51662156301 | 2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)Marketed from Jun 25, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- (Sotradecol) Sodium Tetradecyl Sulfate
- Generic name (nonproprietary)
- (sotradecol) sodium tetradecyl sulfate
- Active ingredients
- Tetradecyl hydrogen sulfate (Ester) — 30 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040541
- Marketing start
- Listing expires
- Identifiers
- Product ID 51662-1563_c59db022-bda9-1732-e053-2a95a90a24f8SPL ID c59db022-bda9-1732-e053-2a95a90a24f8SPL set ID c59db022-bda8-1732-e053-2a95a90a24f8RxCUI 204491UNII 6326W0DRHY
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N451662156301followed by a unit qualifier and the quantityPackage 51662-1563-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.
Excerpt only. Read the full label for complete information.
About NDC 51662-1563
- What is NDC 51662-1563?
- 51662-1563 is the product NDC for (Sotradecol) Sodium Tetradecyl Sulfate, Tetradecyl hydrogen sulfate (Ester) 30 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- (Sotradecol) Sodium Tetradecyl Sulfate.
- What is the active ingredient?
- Tetradecyl hydrogen sulfate (Ester).
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for (Sotradecol) Sodium Tetradecyl Sulfate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 040541
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sodium Tetradecyl Sulfate | Tetradecyl hydrogen sulfate (Ester) 10 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1562 |
| Sotradecoltetradecyl hydrogen sulfate (ester) | Tetradecyl hydrogen sulfate (Ester) 10 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-162 |
| Sotradecoltetradecyl hydrogen sulfate (ester) | Tetradecyl hydrogen sulfate (Ester) 30 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-163 |